PETACH TIKVA, Israel--(BUSINESS WIRE)--
Can-Fite
BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology
company advancing a pipeline of proprietary small molecule drugs that
address cancer, liver and inflammatory diseases, today announced its
near-term milestones for 2018, including events related to the
rheumatoid arthritis/psoriasis drug Piclidenoson and the liver disease
drug Namodenoson.

The Company believes that it is close to reaching certain significant
clinical milestones in its efforts to bring the two lead drug
candidates, Piclidenoson and Namodenoson, to market. Both drug
candidates are administered to patients orally in the form of a tablet
and have demonstrated an excellent safety profile in prior clinical
trials. The below near-term key events provide an outlook of Can-Fite's
objectives and potential for increased growth.

Piclidenoson

A pivotal Phase III study, ACRobat®, for the treatment of
patients with rheumatoid arthritis is currently enrolling patients to
evaluate the drug as a first line treatment and replacement for the
current standard of care, Methotrexate (MTX), the most widely used
drug for rheumatoid arthritis.

A pivotal Phase III study, Comfort®, for the treatment of
patients with moderate-to-severe plaque psoriasis in comparison to
placebo and as compared to apremilast (Otezla®) is expected to
commence during 2018.

Can-Fite expects that these pivotal
Phase III studies will serve as the first of two pivotal studies
required for European Medicines Agency (EMA) drug approval.

Namodenoson

Top-line results from the ongoing Phase II study with
Namodenoson for patients with advanced liver cancer is expected in the
second half of 2018. Enrollment of all 78 subjects in Israel, Europe
and the U.S. has been completed and the Company continues to follow up
on patients’ overall survival.

Phase II study in patients with NAFLD/NASH has commenced in
Israel, and is expected to enroll approximately 60 patients. The
Company aims to complete enrollment for this study in the next twelve
months.

Biomarker

The Company has already developed a high throughput screening assay
which is conducted in a central lab for the evaluation of the A3AR
Biomarker in a small blood sample withdrawn from the patients in each
of the trials. The purpose of analyzing the biomarker prior to
treatment is to help identify an individual patient's responsiveness
to the Company's drugs, providing more personalized medicine. In case
a direct correlation between biomarker level prior to treatment and
patients’ response to the drug is demonstrated, the Company expects
this to have additional commercial applications. The U.S. Patent and
Trademark Office previously issued a patent for the utilization of
A3AR as a biomarker to predict patient response to Piclidenoson in
autoimmune inflammatory indications.

“We are very excited at the opportunity of potentially receiving further
validation of our drug candidates, which represents significant steps
forward in our commitment to delivering treatments to patients. We hope
to see this come to fruition upon conclusion of our various trials,”
stated Can-Fite CEO Dr. Pnina Fishman.

Can-Fite's Piclidenoson and Namodenoson are focused on
multibillion-dollar market opportunities. The rheumatoid arthritis and
psoriasis therapeutic market is dominated by biological drugs that are
primarily administered via intravenous injection (IV) and have potential
side effects. Rheumatoid arthritis and psoriasis are huge unmet-need
markets, where rheumatoid arthritis is estimated to reach $35B in 2020
and psoriasis is forecast to reach $9B in 2018.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI) is an advanced
clinical stage drug development Company with a platform technology that
is designed to address multibillion-dollar markets in the treatment of
cancer, inflammatory disease and sexual dysfunction. The Company’s lead
drug candidate, Piclidenoson, is currently in a Phase III trial for
rheumatoid arthritis and is expected to enter a Phase III trial for
psoriasis during 2018. Can-Fite’s liver cancer drug, Namodenoson, is in
Phase II trials for hepatocellular carcinoma (HCC), the most common form
of liver cancer, and for the treatment of non-alcoholic steatohepatitis
(NASH). Namodenoson has been granted Orphan Drug Designation in the U.S.
and Europe and Fast Track Designation as a second line treatment for HCC
by the U.S. Food and Drug Administration. Namodenoson has also shown
proof of concept to potentially treat other cancers including colon,
prostate and melanoma. CF602, the Company’s third drug candidate, has
shown efficacy in the treatment of erectile dysfunction in preclinical
studies and the Company is investigating additional compounds, targeting
A3AR, for the treatment of sexual dysfunction. These drugs have an
excellent safety profile with experience in over 1,000 patients in
clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements about
Can-Fite’s expectations, beliefs or intentions regarding, among other
things, market risks and uncertainties, its product development efforts,
business, financial condition, results of operations, strategies or
prospects. In addition, from time to time, Can-Fite or its
representatives have made or may make forward-looking statements, orally
or in writing. Forward-looking statements can be identified by the use
of forward-looking words such as “believe,” “expect,” “intend,” “plan,”
“may,” “should” or “anticipate” or their negatives or other variations
of these words or other comparable words or by the fact that these
statements do not relate strictly to historical or current matters.
These forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or with
the approval of one of Can-Fite’s authorized executive officers.
Forward-looking statements relate to anticipated or expected events,
activities, trends or results as of the date they are made. Because
forward-looking statements relate to matters that have not yet occurred,
these statements are inherently subject to risks and uncertainties that
could cause Can-Fite’s actual results to differ materially from any
future results expressed or implied by the forward-looking statements.
Many factors could cause Can-Fite’s actual activities or results to
differ materially from the activities and results anticipated in such
forward-looking statements. Factors that could cause our actual results
to differ materially from those expressed or implied in such
forward-looking statements include, but are not limited to: the
initiation, timing, progress and results of our preclinical studies,
clinical trials and other product candidate development efforts; our
ability to advance our product candidates into clinical trials or to
successfully complete our preclinical studies or clinical trials; our
receipt of regulatory approvals for our product candidates, and the
timing of other regulatory filings and approvals; the clinical
development, commercialization and market acceptance of our product
candidates; our ability to establish and maintain corporate
collaborations; the implementation of our business model and strategic
plans for our business and product candidates; the scope of protection
we are able to establish and maintain for intellectual property rights
covering our product candidates and our ability to operate our business
without infringing the intellectual property rights of others; estimates
of our expenses, future revenues, capital requirements and our needs for
additional financing; competitive companies, technologies and our
industry; statements as to the impact of the political and security
situation in Israel on our business; and risks and other risk factors
detailed in Can-Fite’s filings with the SEC and in its periodic filings
with the TASE. In addition, Can-Fite operates in an industry sector
where securities values are highly volatile and may be influenced by
economic and other factors beyond its control. Can-Fite does not
undertake any obligation to publicly update these forward-looking
statements, whether as a result of new information, future events or
otherwise.